Quality & Compliance

Scientific rigour, institutional credibility

Our clinical research operations are aligned with internationally recognised standards, giving pharmaceutical partners confidence in the integrity of every study we support.

Our Standards

Good Clinical Practice, applied consistently

TDRTI’s clinical research operations follow the ICH E6 (R2) Good Clinical Practice guideline — the internationally agreed standard for designing, conducting, recording, and reporting clinical trials. This means our teams, processes, and documentation are aligned with what pharmaceutical partners and regulators expect from a credible research partner.

Operational Compliance

ICH E6 (R2) GCP-aligned operations
Institutional ethics committee oversight
Standard Operating Procedures (SOPs) in place
GCP-trained investigator and CRA teams
Adverse event reporting protocols
Data integrity and audit trail management
Multilingual informed consent processes

Institutional Oversight

Regulatory submissions to local ethics committees
Site activation, monitoring, and close-out procedures
Source data verification and query resolution
Protocol-aligned participant screening and consent
End-of-study data lock and secure transfer
Ongoing GCP refresher training for site staff

What This Means In Practice

Standards our partners can verify

ICH E6 (R2) — Good Clinical Practice

The international guideline covering how clinical trials should be designed, conducted, recorded, and reported. Our team’s training and our documentation practices are aligned with this standard throughout every study.

Ethics Committee Oversight

All clinical research activities are conducted under the oversight of relevant institutional and regional ethics committees, ensuring participant welfare and informed consent are protected at every stage.

Data Integrity & Audit Trails

Our data collection processes are structured and auditable, with clear documentation from point of collection through to sponsor delivery, supporting the data integrity standards pharmaceutical partners require.

GCP Training

Investigators and site staff working on TDRTI studies complete Good Clinical Practice training aligned with ICH E6 (R2), with certification maintained and available for partner review.